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You are viewing a Web site, archived on 14:28:07 Nov 18, 2004. It is now a Federal record managed by the National Archives and Records Administration.
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Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
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Summaries / Presentations

Summaries and Presentations are in chronological order, with the most recent event at the top of the list.
They will be removed after six months. If you want to keep the slides for future reference, they may be downloaded and saved.

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BioWest 2004 Conference - 10/27/2004

  • CBER Update: Selected Accomplishments and Major Initiatives
          Karen Midthun, M.D. - (PDF)

RAPS 2004 - Annual Conference and Exhibition - 10/12/2004

  • CBER 2004 Update: Innovations Advancing Public Health
          Karen Midthun, M.D. - (PDF)

  • Electronic Submissions - eCTD and Beyond
          Robert A. Yetter, Ph.D. - (PDF)

World Vaccine Congress - 10/11-13/2004

  • Routes to Expedite Vaccine Approvals
          William M. Egan, Ph.D. - (PDF)

CBER Critical Path Workshop - 10/7/2004

  • Working With Stakeholders on Scientific Opportunities for Biologics Products
          Jesse L. Goodman, M.D. M.P.H. - (PDF)

  • Risk Assessment Through the Product Life Cycle: How Can We Do Better?
          June S. Almenoff MD, PhD, FACP - (PDF)

  • Critical Path Initiative - The Role of Good Clinical Practice and Manufacturing Science in New Drug Development - Critical Path Opportunities and CBER/OCBQ
          James S. Cohen, J.D. - (PDF)

  • Statistics, Risk Management and Clinical Trial Design
          Susan S. Ellenberg, Ph.D. - (PDF)

  • Critical Path Opportunities in OBRR/CBER
          Jay S. Epstein, M.D. - (PDF)

  • Critical Path: OCTGT Perspective
          Joyce L. Frey, Ph.D. - (PDF)

  • Scientific Opportunities for Facilitating Development of Blood and Blood Products
          Jonathan C. Goldsmith, MD - (PDF)

  • Office of Vaccines Research and Review
          Jerry P. Weir, Ph.D. - (PDF)

2004 PDA/FDA Joint Regulatory Conference - 9/20-22/2004

  • Bovine-derived Products Used in the Manufacture and Formulation of Vaccines: Current Policies and Issues for the Future
          William M. Egan, Ph.D. - (PDF)

Scientific Considerations Related to Developing Follow-On Protein Products - 9/14-15/2004

FDLI Conference: Advertising and Promotion for the Pharmaceutical, Veterinary Medicine, Biologics, and Medical Device Industries - 9/13-14/2004

  • CBER Update: Advertising and Promotional Labeling Branch (APLB)
          Glenn N. Byrd, MBA, RAC - (PDF)

FDA Plasma Standards Workshop - 8/31/2004

  • Recovered Plasma: Proposed Requirements for Plasma for Manufacture
          Susan L. Wilkinson, EdD - (PDF)

  • Governmental Regulatory Requirements and Rationale: Canada
          T.W. Walker, Ph.D., P.Eng. - (PDF)

  • Freezing and Storage of Source Plasma
          Jim Viane, ZLB Plasma Services - (PDF)

  • Plasma Standards and The American Association of Blood Banks (AABB)
          Susan L. Wilkinson, EdD - (PDF)

  • FDA Plasma Workshop
          Peter L. Page, MD - (PDF)

  • FDA Plasma Workshop (2)
          Peter L. Page, MD - (PDF)

  • FDA Workshop on Plasma Standards
          Celso Bianco, MD - (PDF)

  • Plasma for Fractionation: A Fractionator's Perspective
          Daniel Albrecht - (PDF)

  • FDA Plasma Standards Workshop
          Mary Ann Lamb, Ph.D. - (PDF)

  • FDA Plasma Workshop
          Roger Brinser, Sr. - (PDF)

  • Plasma Standards Workshop
          Jay S. Epstein, M.D. - (PDF)

  • Governmental Regulatory Requirements for "Plasma for Fractionation" in Europe
          Johannes Dodt - (PDF)

  • Need for High Quality Plasma Derivatives
          Donna DiMichele, MD - (PDF)

  • Summary of the June 20, 2003 BPAC
          Elizabeth Callaghan, MD - (PDF)

  • Impact of Change to Existing Regulations
          Roger Brinser, Sr. - (PDF)

  • FDA Requirements for Plasma Components
          Sharyn Orton, Ph.D. - (PDF)

  • Manufacturing Standards for Plasma for Fractionation - Australian Regulatory Requirements
          Albert Farrugia - (PDF)

  • Manufacturing Standards for Plasma for Fractionation - Scientific Relevance and Requlatory Requirements
          Albert Farrugia - (PDF)

  • Current Practices in Freezing and Storage
          G. Michael Fitzpatrick, Ph.D. - (PDF)

  • FDA Plasma Standards Workshop
          Barbara Glantschnig, MSc. - (PDF)

  • Overview of Plasma Fractionation Practices
          Mary Gustafson - (PDF)

  • PPTA Comments on Recovered Plasma
          Mary Gustafson - (PDF)

  • FDA Plasma Standards Workshop
          Jonathan Knowles, Dr.P.H. - (PDF)

9th Annual GMP By The Sea - 8/23-25/2004

  • CBER Update on Risk-Based Initiatives for Regulated Products
          James S. Cohen, J.D. - (PDF)

  • Risk Based Quality for Emerging Biotech Processes and Products
          John Finkbohner, Ph.D. - (PDF)

  • The Risk-Based Outlook for Internationally Harmonized CGMPS
          Chris Joneckis, Ph.D. - (PDF)

Third Annual Research, Technologies and Applications in Biodefense - 8/18/2004

  • Fast-Tracking Biodefense Vaccines and Therapeutics : An Urgent Challenge We Must Meet
          Cynthia L. Kelley, M.S. - (PDF)

DIA 40th Annual Meeting - 6/13-17/2004

  • CBER Update
          Karen Midthun, M.D. - (PDF), (Text)

  • CBER Update: Advertising and Promotional Labeling Branch (APLB)
          Glenn N. Byrd, MBA, RAC - (PDF)

Strategies For Developing Therapeutics That Directly Target Anthrax and Its Toxins - 6/10/2004

  • Inhalation Studies for Non-human Primates and Rabbits
          Roy Barnewall, D.V.M., Ph.D. - (PDF)

  • Some New Inhibitors of Anthrax Toxin
          R. John Collier, Ph.D. - (PDF)

  • The Strategic National Stockpile Program
          Sue Gorman, Pharm.D. - (PDF)

  • Clinical Pharmacology and the Development of Products for the Treatment of Anthrax
          Martin D. Green, Ph.D., AD P/T - (PDF)

  • NIAID Opportunities & Resources for Biodefense Countermeasures Research & Development
          Judy Hewitt, Ph.D., - (PDF)

  • Anthrax Toxin as a Target for Therapeutics
          Stephen H. Leppla, Ph.D. - (PDF)

  • Animal Models for Testing Therapeutics
          Julie Lovchik, Ph.D. - (PDF)

  • GLPs Related to the Development of Countermeasures
          James F. McCormack, Ph.D. - (PDF)

  • Manufacturing and Testing of Polyclonal Antibody Preparations
          Jenny Mellquist-Riemenschneider, Ph.D. - (PDF)

  • Acquisition of Medical Countermeasures for Biodefense - DHHS Plans for Implementation of Project BioShield
          Marissa A. Miller, DVM, MPH - (PDF)

  • Challenges and Opportunities in Product Development - An Overview from 30,000 ft.
          Carl Nielsen, Ph.D. - (PDF)

  • Animal Models for B. anthracis Infection
          M. Louise M. Pitt, Ph.D. - (PDF)

  • In Vitro Assays for Anti-Toxin Therapies
          Conrad P. Quinn, Ph.D. - (PDF)

  • Clinical Safety Testing in Healthy Volunteers
          David Ross, M.D., Ph.D. - (PDF)

  • The Animal Rule Applied: Pyridostigmine for Nerve Gas Exposure and Gentamicin for Plague
          Lewis K. Schrager, M.D. - (PDF)

  • Clinical Aspects of Anthrax: Lessons of the 2001 Outbreak
          David S. Stephens, M.D. - (PDF)

BIO 2004 Global Regulatory Town Hall Meeting - 6/8/2004

  • CBER 2004: Innovation Advancing Public Health
          Jesse L. Goodman, MD, MPH - (PDF)

The 7th Annual FDA-OCRA Educational Conference - “Solutions to Regulatory Challenges” - 6/2-3/2004

  • GMP: Current Compliance Issues for Biologics
          James S. Cohen, J.D. - (PDF), (Text)

PhRMA 2004 Biologics and Biotechnology Meeting - 5/25/2004

National Foundation for Infectious Diseases: Seventh Annual Vaccines Research Conference - 5/24-26/2004

  • Accelerated Pathways for Emergency Vaccines and Other Vaccines of Public Health Importance
          William M. Egan, Ph.D. - (PDF), (Text)

Institute for International Research - 1/19-21/2004

  • Understanding Lyophilization Regulations, Being Prepared for FDA Audits & Review Issues
          Robert Darius - (PDF)

 

 
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